Tracking Regulatory Requirements

John Russell

March 16, 2010 | The Russell Transcript | Given the massive effort required to win regulatory approval for a new drug, it is easy to understand the euphoria surrounding agency approval following an NDA submission, but for internal ‘regulatory affairs’ teams, the work isn’t done. Ensuring compliance with post-marketing requirements is a daunting task for even one approved drug, let alone a portfolio of many.

Whippany, NJ–basedISI, long a leader in submission software and consultancy services, has for the past few years pushed into post-marketing services and tools. “The problem is there is all this information about what products are registered, for which markets, what the details for manufacturing are, etc.,” says Kate Wilbur, director of regulatory services at ISI. “Pharma companies are really having trouble pulling it all together. It’s all a question of having theses little bits and pieces of information that are all part of the license approval.”

For the regulatory affairs function inside biopharma, the failure to have needed information can delay critical decisions, draw regulator agency ire, and harm the company and patients. J&J’s massive recall of several products in late 2009—the FDA sharply criticized J&J for its relative slowness to act—is just another high-profile example of a pharma having trouble dealing with a post-marketing problem. The practical truth, says Wilbur, is few drug companies have adequate post-marketing tracking systems. “Very few companies have an overview of that essential information in one place for all of their products,” she says.

There are lots of homegrown solutions available. Often solutions tracking one product don’t link to systems tracking other products to provide decision makers with a comprehensive overview. “You might have a different spreadsheet for each of your sites,” says Wilbur. Deployed properly, commercial tools can help drug companies not only respond to problems but also evaluate portfolios to drive business goals. ISI offers RegTracker, an Oracle-based software package whose newest release, version 4.2, is scheduled for April. Like similar products, it is highly configurable. Wilbur says RegTracker’s reporting features are especially strong, and that a user interface can readily be put on the web allowing easy access company wide.

However, such sophisticated tools are not trivial to deploy. It can take two months for a small company with one or two approved compounds, six months for moderate size company, and 12-18 months for a big pharma. Moreover, while the FDA and other agencies have issued myriad post-marketing requirements to follow, they haven’t mandated how needed information needed should be tracked.

There is typically a substantial services component required when deploying a commercial regulatory tracking product. Indeed, Wilbur says ISI’s business is roughly a 50/50 split between software and services. The payoff in using systems like RegTracker is that companies get a single comprehensive view of their post-marketing activities in terms of regulatory requirements.

“Depending on what you choose to track, it could be possible to discover an issue at a particular site and then see every single product manufactured at this site [and] identify other products impacted,” she says. “If they go to an even deeper level they could see not just which products are manufactured at the site but also which products are stored there and potentially even specific storage conditions.”

Track What?

A major challenge is choosing the right data to track as well as to ensure the data you have tracked us clean. The old adage “garbage in/garbage out” applies strongly in these deployments. Wilbur says ISI has “best practice” methodology it follows in helping clients deploy RegTracker and that the process has solid milestones.

In theory the same drivers that are prompting the biopharmaceutical industry to embrace outsourcing generally—e.g., cost pressure, focus on core competencies, reduced IT resources—should also be driving the industry to use more commercial software for tracking critical regulatory required information and executive decision support.

Wilbur says those forces are nudging the industry forward, but that the pace is measured and varies. Smaller companies tend to see the longer-term potential and can get started more quickly. Larger companies are often wary of lengthy deployments and painful data migration efforts. However recent mergers and acquisitions—and the necessary systems integration projects they create—are inclining large companies to look more favorably at commercial solutions to consolidate their view of regulatory-governed activities.

Deployment isn’t easy. ISI conducted focus groups to gauge customer needs and worries. “Data entry is incredibly underestimated,” says Wilbur. “While it’s nice to have automated data mapping, nine times out of ten it is going to cost more than actually doing manual data entry and manual data cleanup. We understand this and we also understand that making sure we get the data from existing systems into the new system is going to be one of the key priorities of the implementation.”

This article also appeared in the March-April 2010 issue of Bio-IT World Magazine.
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